Percutaneous left atrial appendage occlusion: The Munich consensus document on definitions, endpoints, and data collection requirements for clinical studies

Apostolos Tzikas, David R. Holmes, Sameer Gafoor, Carlos E. Ruiz, Carina Blomstrom-Lundqvist, Hans Christoph Diener, Riccardo Cappato, Saibal Kar, Randal J. Lee, Robert A. Byrne, Reda Ibrahim, Dhanunjaya Lakkireddy, Osama I. Soliman, Michael Nabauer, Steffen Schneider, Johannes Brachmann, Jeffrey L. Saver, Klaus Tiemann, Horst Sievert, A. John CammThorsten Lewalter

Research output: Contribution to journalArticle

58 Scopus citations

Abstract

The increasing interest in left atrial appendage occlusion (LAAO) for ischaemic stroke prevention in atrial fibrillation (AF) fuels the need for more clinical data on the safety and effectiveness of this therapy. Besides an assessment of the effectiveness of the therapy in specific patients groups, comparisons with pharmacological stroke prophylaxis, surgical approaches, and other device-based therapies are warranted. This paper documents the consensus reached among clinical experts in relevant disciplines from Europe and North America, European cardiology professional societies, and representatives from the medical device industry regarding definitions for parameters and endpoints to be assessed in clinical studies. Adherence to these definitions is proposed in order to achieve a consistent approach across clinical studies on LAAOamong the involved stakeholders and various clinical disciplines and thereby facilitate continued evaluation of therapeutic strategies available.

Original languageEnglish (US)
Pages (from-to)4-15
Number of pages12
JournalEuropace
Volume19
Issue number1
DOIs
StatePublished - 2017

Keywords

  • Atrial Fibrillation
  • LAA closure
  • Prevention
  • Stroke

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Physiology (medical)

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